Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622791
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Brief Summary:

Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.

Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.

Condition or disease
Coronary Artery Disease Cardiopulmonary Bypass Coronary Artery Bypass Graft

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

CABG group
Patients undergoing coronary artery bypass graft with cardiopulmonary bypass
OPCAB group
Patients undergoing off-pump coronary artery bypass graft

Primary Outcome Measures :
  1. Propofol pharmacodynamics and pharmacokinetics

Biospecimen Retention:   Samples Without DNA
Blood samples

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Twenty patients undergoing elective coronary artery bypass graft surgery

Inclusion Criteria:

  • Isolated coronary artery bypass indication
  • Left ventricular ejection fraction greater than 50 %
  • Absence of preoperative pulmonary dysfunction

Exclusion Criteria:

  • Intra and postoperative circulatory shock
  • Postoperative pulmonary dysfunction

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622791

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Maria M Carmona, MD PhD Faculdade de Medicina da Universidade de São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maria J. C. Carmona, Faculdade de Medicina da Universidade de São Paulo Identifier: NCT00622791     History of Changes
Other Study ID Numbers: 802-01
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: February 2008

Keywords provided by University of Sao Paulo:
Cardiopulmonary bypass
coronary artery bypass graft
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General